What happens when widely read Wall Street analysts email all of their clients with details about studies appearing in the New England Journal of Medicine before the embargo lifts? Will NEJM lift the embargo early, or force reporters who’ve agreed to their embargo to wait and face sanctions for breaking it?

That question is not merely academic. Yesterday, a day before the embargo on this week’s NEJM lifted, Geoff Meacham of JP Morgan sent an email to his clients that included the following:

In a related note, the July 15th edition of the NEJM, Dr. Patricia Severe and colleagues from GHESKIO (AIDS and TB research clinical in Haiti) and Cornell published a paper that continues to support early initiation of anti-retroviral therapy (ART) as opposed to waiting until CD4 counts decline below 350/mm3. This follows multiple studies including NA-ACCORD which support early use of ART which can lead to a survival benefit over waiting.

In the Severe et al study, 816 HIV+ patients were randomized 1:1 to Combivir + Sustiva in the “early treatment group” (CD4 counts between 200 and 350) versus the same regimen in the “standard treatment group” (waiting until CD4 counts go below 200). The median follow up was 21 months and the baseline CD4 count was ~280 in both groups.

Overall survival was meaningfully better in the “early” group with 6 deaths compared to 23 deaths in the “standard” group (HR= 4.0; CI: 1.6 – 9.8; p=0.001). In addition, there were 36 cases of tuberculosis in the “standard” group and 18 in the “early” group (HR=2.0; CI: 1.2-3.6; p=0.01).

ARNA (BUY), The BLOOM trial is published today in the NEJM with an editorial. The editorial points out that lorcaserin has slightly less than or equal efficacy to Orlistat and slightly less effiacy than Meridia (sibutramine). However the justification of approval for lorcaserin is that its safety profile appears to be better than that of Xenical (orlistat) or sibutramine. In addition, lorcaserin appears to result in improvement of all surrogate measures of diabetes and cardiovascular risk: the effect is small however clinically relevant. This is important since sibutramine did not and subsequently went on to demonstrate negative cardiovascular outcome in the SCOUT trial. The SCOUT trial results will be presented tomorrow at the International Obestity conference in Stockholm. The author of the editorial suggests that lorcaserin will probably be used in combination, perhaps with GLP-1s (prior to phentermine). Overall we consider the publication a positive for the shares and it bodes well for the September 16th advisory panel meeting (bolsters the Eisai deal — safety first novel agent).

There’s a lot of inconsistency in what it takes to get an embargo lifted early, but I don’t think there’s a press officer at any journal that would say there aren’t enough details in those two notes to justify a lift if they had appeared in press reports.

But those weren’t in press reports, they were notes to clients from Wall Street analysts who had never agreed to an embargo. NEJM did not lift the embargo early.

So you can add “Wall Street analyst memos” to the list of pre-embargo reports that won’t trigger an early lift. That list already includes:

Journalists who agree to embargoes have to sit idly by while all of those reports make their way around the Web.

You can also add “Wall Street analysts” to the list of those who can publish such reports with impunity, since they never agreed to the embargoes in the first place. That list of course includes Jonathan Leake and some other reporters, as well as the aforementioned press release writers.

Adam Feuerstein, no stranger to embargo frustration, sent me the two analysts’ notes last night. He posted a story on them this morning, after talking to NEJM about their policy. (Given that I’m at a large news organization, with many people who have agreed to NEJM’s embargo, all of whom could lose access if the journal decided a post on this before the embargo lifted was a break, I kept to usual Embargo Watch custom and waited until the embargo lifted just now to post.)

As usual, Adam hits the nail on the head, and describes the ethical tightrope he’s walking, as one of his commenters put it, by posting the story:

Yet, if I had published stories Tuesday similarly informing readers about studies related to Arena and Gilead published in this week’s NEJM, the journal editors would have screamed foul. [And they may be doing exactly that as they read this column.]

Later in the piece, he wrote:

My primary responsibility is to bring this information to the attention of my readers — largely retail investors — as soon as possible. I respect embargoes and will therefore not quote directly from this week’s NEJM until the embargo lifts tonight at 5 pm EDT. However, I should not be prevented from reporting on, or reprinting the work of, an analyst who is not constrained by any embargo.

According to Adam:

Jennifer Zeis, a spokesperson for the NEJM, acknowledged this situation is “not ideal,” but she argued that embargoes have an important role and therefore need to be enforced, even in cases where some people gain access to NEJM information before others.

I respectfully disagreed with her. (We actually had a good conversation about embargoes and I appreciate her listening to my point of view.)

By late afternoon, Adam hadn’t heard anything from NEJM about his post.

As you know, we mail our printed issues in advance of the embargo. The embargo on news stories helps to ensure that our physician readers have the information before their patients hear about it on the news. The printed issues are not “embargoed,” as this would be impossible to enforce.

I see the difficulty in enforcing the embargo because of the mailing schedule, but as I’ve noted before, it’s also hard to defend an embargo of something that’s already available to so many people. This, it would seem, is NEJM’s version of “available for subscribers, but embargoed.”

Which begs the question: What if a reporter just subscribed to NEJM, and wrote about studies as soon as they arrived in her snail mail box? She’d give up access to the many studies NEJM, like other journals, publishes early or exclusively online. So it’s probably not something anyone who really wants access to NEJM will try. But like the hypotheticals in Brian Reid’s Embargo Watch guest post, it’s interesting to think about.

4 Responses

I love it. Years ago I raised the spectre of “insider trading” on the back of embargoed press releases about drug trials. (That was back in the time when the science press didn’t know what shares were all about.)

Little did I know that the day would come when it was the other way round.

The idea that printed copies can land before the death of an embargo is bizarre.

First, the notion of Wall Street types gaining access to, and acting on, potentially market-moving studies before an embargo lifts is nothing new. I recall reports of a few such situations when I was JAMA’s science news officer almost 25 years ago, in the early days of statins and dietary aids for cholesterol control (oat bran, anyone?). Analysts simply got a subscription to the print journal and acted accordingly when it arrived in their mailboxes, since even a few hours advance warning is a major advantage. And of course, analysts have been regular attendees for years at major clinical meetings, where data that eventually ends up in some of the same journals is first presented.

The mention of whether a reporter could simply get a journal subscription and work from that on any schedule that he or she chose, though that would risk the journal’s wrath, reminded me of a medical writer friend who sort of took that path, though not by choice. Arguing that he was falsely accused of an intentional embargo break that resulted in his being tossed off the journal’s press list, the reporter, as I recall, simply relied on a physician friend with a subscription to provide the journal to him. Being under no obligation to follow the embargo associated with the advance media access that he’d been denied (incorrectly, he argued), he did his work without it. And it drove the journal nuts.

All was resolved eventually, but it was just one more example, from the dustbin of history, of how fragile, frustrating and sometimes just plain silly, a system like this can be.

I’ve experienced another frustrating side of the NEJM embargoes as a subscriber.

At ASCO, some key articles were clearly circulated under embargo to some journalists in advance while paying subscribers such as myself had to wait until the meeting to obtain copies from Publishers Row in the exhibits.

My experience is that embargoed releases typically occur in advance of the printed copy. I wouldn’t mind if they gave us poor subscribers early online access at the same time as the journalists, but we’re usually the last to read them, sadly.

Clinical trials are almost a gaurantee of success if the Scout study of Sibutramine is anything tio go by.
In that study, they carried out a pretrial, excluded anyone who suffered an adverse event, then carried out the main trial, which, naturally went on to be a stunning success.
Quite amazing, soon they will decide there is no need for trials at all.